This study is designed to examine the effects on post operative pain after the use of a
fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The
fixation devices to be used differ with one being made from titanium and is permanent and the
other being made from an absorbable material. Both fixation devices are commonly used but two
questions remain unanswered, does one cause more chronic pain and also what if any will be
the effect on recurrence rates of the hernia. No trial has been undertaken to date which will
not only examine the fixation device but in the setting where the hernia is closed first. The
closure of the hernial defect by the keyhole technique is a relatively new and growing
concept in the hernia world.

Incisional hernias are a frequent consequence of abdominal surgery. Current clinical efforts
are primarily focused on improving repair materials and surgical techniques to correct these
hernias instead of the optimal solution: prevention.
A product called MYOSEAL is currently being developed to prevent hernia formation after
abdominal surgery by using fibrin tissue sealant and silver particles to prophylactically
enhance the early wound healing of myofascial incisions. The purpose of this phase 1 study is
to examine the safety of applying MYOSEAL immediately after abdominal wall suture closure in
patients undergoing abdominal surgery. The investigators expect that applying this product to
sutured myofascial incisions will increase collagen formation in the wound and thus prevent
the formation of incisional hernias.

The purpose of this study is to:
1. compare the long term results of mesh versus suture repair in treatment of abdominal
wall defects;
2. find the optimal location of implanted prosthesis, comparing the two most useful
position of mesh in abdominal wall hernia surgery.

Increasingly in general surgery, the investigators are conducting outpatient day surgery.
Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America.
These patients all require some form of analgesia which can be taken at home in the first
few days after the surgery. The current standard at the investigators' centre and many
others in the maritime provinces is to provide a prescription for oral acetaminophen plus
codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent
opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed
medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side
effects, and may not provide effective pain relief. In the investigators' experience,
non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home
analgesic regimen.
Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain
medication. They hope to show that a combination of ibuprofen and acetaminophen is better
for pain relief after these procedures. The combination of acetaminophen and ibuprofen would
be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices
of surgeons are old habits, it will require a very convincing argument to get them to change
their practices. A randomized controlled trial comparing these two regimens, the
investigators hope, would be a powerful enough argument.
The hypothesis of this study, therefore, is that the pain control provided by a combination
of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to
Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day).
This study will attempt to enroll 150 patients in total. Eligible patients will be
identified by their attending surgeon and contacted by study personnel. Patients who enroll
in the study will undergo their surgery in the usual manner. After the surgery, in the
recovery room, once they are ready to go home, they will be randomized to receive
combination A or B and be given a week's worth of pain medication. They will then go home
and take this medication as directed. They will record their pain intensity and pain relief
once per day using a diary provided in the study package. One week after their surgery, they
will return to the hospital clinic and be seen by the study nurse. They will hand over the
diary and any unused medication. They will also be asked several questions regarding their
overall satisfaction, incidence of side effects, and how long until they were pain free.
The risks of participating in this study are minimal from the risks inherent to the
procedures and medications the patients would receive within the standard of care. Ibuprofen
is a commonly used NSAID which is widely available over the counter and has an established
safety profile. The most common adverse effects of ibuprofen and other NSAIDs are
gastrointestinal bleeding and ulceration. Other less common adverse effects include
nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and
cognitive dysfunction. The investigators' patients will be selected to exclude those most at
risk for these complications (see exclusion criteria). Acetaminophen has few side effects,
with no adverse effects on platelet function and no evidence of gastric irritation.

The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia
repair using an intraperitoneally placed Proceed mesh, looking at postoperative
complications, recurrence rate and postoperative pain and quality of life.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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